AB0388 FRENCH REAL LIFE SAFETY DATA ON THE USE OF TOFACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS: OBSERVATIONAL STUDY, DeFacTo
Authors: C. Gaujoux-Viala, A. Basch, S. Lassoued, F. Coury-Lucas, M. Kessouri, N. Mammar, Y. Brault, T. Lequerre, C. Salliot
Journal: Annals of the Rheumatic Diseases (2022)

Background Tofacitinib, an oral Janus Kinase inhibitor, is indicated in the treatment of adult patients (pts) with active, moderate to severe rheumatoid arthritis (RA). Objectives The objective of this work is to describe the tofacitinib’s safety profile in the DeFacTo study (French prospective observational study). Methods The safety profile of tofacitinib was assessed on the basis of interim data from a descriptive analysis of pts having taken at least one dose of tofacitinib in the context of the DeFacTo study. Results Of the 313 pts enrolled in the study, 301 had received tofacitinib and were included in the safety analysis. Of these, 276 fulfilled the eligibility criteria and included 219 who had ≥ 1 year follow-up and a mean exposure period of 368 ± 197.1 days. As of 15 March 2021, 122 patients are continuing to take tofacitinib therapy (76 missing prescription data). On inclusion, 77.9% of the 276 pts were females of mean (± SD) age 59.7 ± 11.7 years and a median disease duration of 9.1 years [Q1;Q3: 4.1; 19.2]. A history of cardiovascular disease was found in 12.5% of cases, (4.4% myocardial infraction, 5.5% stroke/transient ischemic attack, 1.5% heart failure and 1.5% peripheral arterial occlusive disease); 5.5% had a history of cancer, 17.5% a prior infection and 46% were smokers/former smokers. Tofacitinib was prescribed in combination with a csDMARD in 58.3% of pts and with corticosteroids in 54.3% of cases. At the cut-off date of 15 March 2021, of the 301 patients, adverse effects (AE) had been reported in 44.9% of cases of which 10.6% were considered serious (SAE). Infections were detected in 18.6% of pts (Table 1). Table 1. Real life safety data for tofacitinib according to age N, (%) &lt; 65 years (n=190) ≥ 65 years (n=110) Total (n=301*) Adverse effect 80 (42.1) 55 (50.0) 135 (44.9) Serious adverse effect 16 (8.4) 16 (14.5) 32 (10.6) Infection 33 (17.4) 23 (20.9) 56 (18.6) Severe infection 3 (1.6) 4 (3.6) 7 (2.3) AE of interest (number of events) Infection Herpes zoster 5 5 10 Severe infection Herpes zoster 1 0 1 Tuberculosis 0 2 2 Cancer Small-cell carcinoma 0 1 1 MACE Stroke 1 0 1 Thromboembolic events Venous thrombosis 0 1 1 Death 0 0 0 *1 patient for whom age is unknown but is counted in the total. Conclusion These purely descriptive interim results reveal a safety profile for tofacitinib in patients with RA, similar to that previously reported in clinical and observational studies. (1-2) References [1]Wollenhaupt et al . Arthritis Research &amp; Therapy (2019) 21:89 https://doi.org/10.1186/s13075-019-1866-2 [2]Kremer et al . ACR Open Rheumatology 2021. DOI 10.1002/acr2.11232 Acknowledgements To all investigators involved in this study, and all patients included in this study Disclosure of Interests Cécile Gaujoux-Viala Speakers bureau: AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Consultant of: AbbVie; Amgen; Boeringhe; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Andre BASCH Speakers bureau: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB, Consultant of: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB,, Slim Lassoued: None declared, Fabienne COURY-LUCAS Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, MSD, Novartis and Pfizer, Grant/research support from: AbbVie, Biogen, Roche Chugai, Pfizer, and UCB,, Meriem Kessouri Shareholder of: Pfizer, Employee of: Pfizer, Nadir Mammar Shareholder of: Pfizer, Employee of: Pfizer, Yves Brault Shareholder of: Pfizer, Employee of: Pfizer, Thierry Lequerre Consultant of: Abbvie, BMS, Boeringher, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche – Chugai, Sanofi, UCB,, Carine Salliot Consultant of: Biogen, Lilly, Novartis, Roche Chugai, Pfizer